Effectiveness of Implementing Best Care Practices in the Management of Patients With Acute Stroke in Conventional Hospitalization: A Cluster-Randomized, Open, Stepped-Wedge Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 4
研究概览
简要总结
The goal of this clinical trial is to evaluate whether a multicomponent nurse-led intervention (BEST CARE ICTUS_HC) can reduce stroke-related complications and improve recovery in adults (18 years and older) hospitalized with an acute ischemic or hemorrhagic stroke in hospitals without specialized Stroke Units. The main questions it aims to answer are:
- Does the implementation of the program increase the early and correct detection of swallowing difficulties (dysphagia) to prevent pneumonia?
- Does the program reduce the severity of attention problems (hemineglect) and improve the patients' quality of life up to 6 months after discharge?
Researchers will compare patients receiving the BEST CARE ICTUS_HC program to patients receiving usual hospital care to see if this new approach improves patient safety and long-term functional recovery.
Participants will:
- Receive either the usual hospital care for stroke or the BEST CARE ICTUS_HC nursing program, depending on the study phase of the hospital.
- Be screened for swallowing problems using a standardized test before receiving any food or drink.
- Be cared for in an adapted environment (FLECHA Project) that uses visual signs and room organization to help with orientation and safety.
- Have their temperature, blood sugar, and blood pressure monitored under a strict specialized protocol.
- Be contacted by phone 30 days and 6 months after leaving the hospital to answer questions about their health and quality of life.
详细描述
#Background and Context# Significant disparities exist in acute stroke outcomes depending on the type of hospital where a patient is admitted. In the Province of Malaga, peripheral hospitals lack specialized Stroke Units, meaning patients are managed in general internal medicine or standard hospitalization wards. Evidence suggests that nurse-led protocols (such as the FeSS protocols) can reduce mortality and complications like Stroke-Associated Pneumonia (SAP), yet these are rarely standardized in non-specialized settings.
The BEST CARE ICTUS_HC model aims to bridge this gap by implementing a structured bundle of care designed to minimize preventable complications and standardize nursing excellence in these peripheral centers.
The study follows the RE-AIM framework to assess reach, effectiveness, adoption, implementation, and maintenance. In accordance with the RE-AIM framework, the study will go beyond mere clinical efficacy to analyze how the intervention's integration into routine practice modifies professional behaviors and healthcare delivery processes.
#Description of the intervention#
The intervention employs a five-pillar strategy to enhance patient safety and clinical outcomes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older.
- •Clinical diagnosis of acute ischemic or hemorrhagic stroke.
- •Admission to conventional hospitalization units (Internal Medicine) in regional hospitals without specialized Stroke Units.
排除标准
- •Patients admitted for a cause other than stroke who develop a stroke during their hospital stay (in-hospital stroke).
- •Patients subjected to invasive neurological procedures.
- •Patients undergoing invasive procedures, such as thrombectomy, who require transfer to a referral hospital and remain there for more than 48 hours.
- •Patients with deterioration of the level of consciousness that prevents the performance of dysphagia testing.
- •Patients that have been taken care of by Nurses and Nursing Assistants with >4 weeks of work experience in Stroke Units in the last 12 months
研究者
JOSE MIGUEL MORALES ASENCIO
Professor / Principal Investigator
University of Malaga